Regulatory Affairs Chemistry Manufacturing Leader

1 semana atrás


Lisboa, Lisboa, Portugal Organón Tempo inteiro

Job Overview

The Organon Manufacturing & Supply (OMS) is seeking a highly skilled Associate Director, Regulatory Affairs Chemistry Manufacturing to provide regulatory support for network projects. This role will lead the preparation and submission of CMC dossiers for assigned network projects.

About the Role

This position will oversee the preparation and submission of Global CMC dossiers for assigned Network projects. You will be responsible for managing processes and connections between external partners and various stakeholders within CMC. A strong track record of demonstrated knowledge of CMC life cycle management and eCTD is essential for the successful candidate.

Key Responsibilities

  • Manage processes and connections between external partners and various stakeholders within CMC
  • Oversee the preparation and submission of Global CMC dossiers for assigned Network projects
  • Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high-quality delivery of business commitments
  • Actively monitor, facilitate, report, and communicate progress against agreed timelines, proactively resolving issues to enable delivery of high-quality, on-time submission information
  • Escalate potential delays or performance issues promptly to impacted, cross-functional stakeholders

Requirements

To be considered for this role, you should have a Bachelor's degree in a science, engineering, or a related field with a minimum of 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field. Alternatively, an advanced degree (MS, MBA, Ph.D., PharmD) with a minimum of 4 years of relevant experience is required.

Compensation

The estimated annual salary for this role is $120,000 - $160,000 depending on qualifications and experience.



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